Clinical Trials Regulatory Lead

RIH Rhode Island Hospital; United States; On-site; USD 58,000 - 96,000; Full time

Job summary

Brown University Health seeks a Regulatory Coordinator to oversee regulatory aspects of clinical research for the department. The role includes coordinating IND/IDE submissions, advising staff on regulatory issues, and partnering with investigators to ensure compliance from study initiation to closeout.

The incumbent will mentor staff, develop and revise regulatory policies, and drive process improvements while maintaining alignment with corporate compliance and FDA guidelines.

Qualifications

• Bachelor’s degree in health-related or scientific field is required.
• Sound knowledge of all federal, local and state guidelines pertaining to Clinical Research.
• Independent person capable of making sound judgments pertaining to regulatory issues and the ability to work independently within job requirements.
• Strong written and verbal communication skills.
• SOCRA certified or eligible within 18 months of hire.

Responsibilities

• Consults with and/or provides advice regarding regulatory documents and/or processes related to clinical trials conduct.
• Serves as the regulatory subject matter expert through all phases of clinical study.
• Mentors other clinical research staff and leads new initiatives and process improvement.
• Develops and/or revises regulatory policies and procedures.
• Initiates and leads special projects, including process improvement and regulatory training.
• Ensures proper regulatory compliance in accordance with sponsoring agency requirements.
• Liases with sponsors, investigators and team members, providing trial information and updates as required.
• Prepares regulatory approval applications, responds to stipulations, and shepherds applications through approvals.

Skills

Regulatory knowledge

Mentoring staff

Process improvement

Education

Bachelor’s degree in health-related or scientific field

Tools

Microsoft Office

Job description

Brown University Health seeks a Regulatory Coordinator to oversee regulatory aspects of clinical research for the department. The role includes coordinating IND/IDE submissions, advising staff on regulatory issues, and partnering with investigators to ensure compliance from study initiation to closeout.

The incumbent will mentor staff, develop and revise regulatory policies, and drive process improvements while maintaining alignment with corporate compliance and FDA guidelines.